The Diagnostic Benefits of the HyperQTM System in ECG Stress Testing

Myocardial Ischemia Clinical Trial

Official title:

The Diagnostic Benefits of the HyperQTM System in ECG Stress Testing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00449579
• Other study ID #: MAC_01
• Status: Recruiting
• Phase: Phase 3
• First received: March 19, 2007
• Last updated: April 16, 2015
• Start date: August 2006
• Est. completion date: October 2007

Study information

• Verified date: October 2006
• Source: Assuta Hospital Systems
• Contact: Haim Silber, MD
• Phone: 09 7408811
• Email: silber_h[@]mac.org.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The main objective of this study is to determine the usefulness of the HyperQ™ System in improving the positive predictive value of conventional ECG stress testing.

Patients who are referred for stress test will perform an ECG stress test on a treadmill, with high-frequency ECG recording from conventional 12 leads using BSP's HyperQ™ System. Conventional 12 lead ECG, as well as HyperQ™ recordings will be provided by the HyperQ™ System. The results of the conventional test and the HyperQ™ data will be compared, using one of three cardiac tests (stress echocardiography, SPECT myocardial perfusion imaging and angiography) as gold standards.

Statistical analysis will compare the sensitivity, specificity, PPV and NPV of the conventional and HyperQ™ stress ECG in detecting myocardial ischemia.

Description:

The study population will comprise of 1200 patients referred to stress test in three Maccabi clinics or cardiac medical centers. All patients will perform an ECG stress test with high-frequency ECG recording from conventional 12 leads using BSP's HyperQ™ System. The recording will be done without affecting or interfering with any aspect of the normal due course of the test. Standard Bruce protocol or modified Bruce protocol will be used, with standard test termination indications. Two minutes of rest ECG will be recorded prior to stating the protocol.

Following the test, the physician will interpret the test's results in the conventional manner (e.g. ST changes, chest pain, etc) and decide whether the subject should be referred to additional tests.

HyperQ™ data will be analyzed in two phases: (i) Interpretation by the physician in a non-blinded manner one day following the stress test and (ii) after performing all the exercise tests of the study group, blindly to the conventional diagnosis and the HyperQ™ analysis done previously, as well as to other outcomes of imaging procedures. The first HyperQ™ reading will be used to detect the subjects who were positive according to the HyperQ™ system but negative according to the conventional stress testing. These subjects will be referred by the physician to further clinical investigation. The first reading will also be used to assess the physician's interpretation in a scenario that represents a realistic clinical setting, while the second reading will be used to examine the unbiased clinical benefit of HyperQ™ data.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• Subject referred to stress ECG

• Subjects age = 45

• Subject signed an Informed Consent form

Exclusion Criteria:

• Subject with contraindications for stress ECG

• Subject with implantable pacemaker or defibrillator

• Subject with LBBB

• Subject with QRS duration = 110 mSec

• Subject with Wolff-Parkinson-White Syndrome

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Coronary Artery Disease
• Myocardial Ischemia

Intervention

Device:
• Excercise stress test with high frequency ECG recording (HyperQ™ System)

Locations

Country	Name	City	State
Israel	Dr. Silber Clinic	Kfar Saba

Sponsors (2)

Lead Sponsor	Collaborator
Assuta Hospital Systems	BSP Biological Signal Processing Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ST changes
Primary	HyperQ results

External Links

•   HyperQ Technology by BSP Ltd.